The Latex Diaphragm to Prevent HIV Acquisition Among Women: A Female-Controlled, Physical Barrier of the Cervix

Brief Summary

The purpose of this trial is to determine whether using the diaphragm and a lubricant get can reduce women's risk of acquiring an HIV infection.

Detailed Description

This multi-site randomized, controlled trial will measure the effectiveness of the diaphragm in preventing heterosexual acquisition of HIV infection among women. This Phase III study is powered to detect effectiveness (biological efficacy combined with adherence) of 33 percent. Women in South Africa and Zimbabwe (N=4,500) at risk of contracting HIV will be invited to participate and will be followed for up to 24 months, with a total study duration of 4 years. All women will receive safer-sex counseling, free male condoms and diagnosis and treatment of sexually transmitted infections (STIs). Half of the participants will be randomly selected to receive an Ortho All-Flex latex diaphragm and Replens lubricant gel. We will assess whether women using diaphragms and lubricant gel have lower rates of HIV or STI infection than do their non-diaphragm and gel counterparts. Additionally, we will investigate the long-term acceptability of the diaphragm in this study population.

Within six weeks of any pelvic surgery or last pregnancy outcome at the time of screening and enrollment

Presence of clinically apparent lesion(s) with epithelial disruption at enrollment (may enroll after lesion(s) has healed, if otherwise eligible)

Injected illicit drugs in the 12 months prior to screening and enrollment

Blood transfusion or received blood products in 3 months prior to screening and enrollment

Unable or unwilling to insert the diaphragm correctly

Participation in any other clinical trial (including those of a vaginal product or barrier contraceptive). Verification by comparing participant lists to other concurrently running research studies may be conducted if necessary.

Unable to speak English, Zulu, Shona, or Sotho

Other conditions that, in the opinion of the investigator, would constitute contraindications to participation in the study or would compromise ability to comply with the study protocol, such as a major psychiatric disorder

Gender

Female

Ages

18 Years to 49 Years (Adult)

Accepts Healthy Volunteers

Yes

Contacts ICMJE

Contact information is only displayed when the study is recruiting subjects